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510(k) K012119

VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 by Maine Standards Co. — Product Code JJY

K012119 is an FDA 510(k) premarket notification submitted by Maine Standards Co. for the device "VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003". The FDA issued a decision of Substantially Equivalent on August 20, 2001. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Maine Standards Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
July 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Maine Standards Co.

  • K123127 — VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (June 14, 2013)
  • K113524 — VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (January 27, 2012)
  • K103271 — MSC LIPID CONTROL (January 25, 2011)
  • K091225 — VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (June 25, 2009)
  • K090475 — VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (April 16, 2009)
  • K083891 — VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (March 23, 2009)
  • K082067 — MSC LIPID CONTROL (August 22, 2008)
  • K072246 — VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (September 14, 2007)
  • K062501 — VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (September 29, 2006)
  • K053247 — VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (January 13, 2006)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources